New York PBM Bill Poses Potential Threat to Patient Safety

| Brittany McCullough
Law gavel and colorful pills on a wooden desk

As the nation continues to grapple with high drug prices, the role of pharmacy benefit managers (PBMs) has been increasingly called into question. Several states have introduced legislation to regulate PBMs with the goal to increase transparency. New York Legislature’s recent passage of S 6531 is perhaps the most stringent. In my opinion, this legislation could have real-life consequences for patients.

There are several provisions in this bill which have raised stakeholder concerns, however, the addition of §280-a (5)(c) is at the top of my list. This section prohibits a PBM from requiring a pharmacy to “meet any accreditation standard or recertification requirement inconsistent with, more stringent than, or in addition to federal and state requirements for licensure as a pharmacy”.

Accreditation builds on the foundational oversight of a state pharmacy board as shown in this comparison table. It is often used by payers and PBMs to ensure pharmacies within their networks are meeting industry standards. This is particularly important when dealing with specialty medications which typically require special handling, patient education and intense clinical monitoring. As I’ve previously noted, given the risk to patients when dealing with potent medications, the dispensing of specialty drugs is often limited to a specialty pharmacy by pharmaceutical manufacturers, health plans and their PBMs. To demonstrate their competence, PBMs and payers usually require specialty pharmacies to be accredited in order to participate in their network. While there may be legitimate concern about the use of contracting tools to inappropriately steer patients to pharmacies that are owned by or closely affiliated with a PBM, accreditation is a quality tool utilized by payers and PBMs to protect patients.

URAC’s Specialty Pharmacy Accreditation is a comprehensive review that validates the operations of and care management provided by specialty pharmacies based on quality standards as defined by national best practices. In short, it assesses a pharmacy’s ability to deliver quality care to patients receiving complex, expensive medications in a consistent and reliable manner. A failure on the part of a specialty pharmacy to appropriately perform any aspect of the storage, handling, dispensing, delivering, patient education or monitoring associated with specialty drugs could potentially be life threatening. As such, requiring a specialty pharmacy to be accredited is a reasonable expectation to ensure high-quality. It also gives a PBM assurance from an independent party that their network has the capacity to fully provide highly specialized services.

Pharmacies that have achieved URAC's Specialty Pharmacy Accreditation have demonstrated their ability to safely dispense and effectively manage the care of patients that require increasingly complex medications. New York moving to enact a law that will prohibit a PBM from requiring accreditation will place patients in harm’s way because they may be subject to receiving care from pharmacies that are ill-prepared to handle specialty drugs. Limiting network contracting criteria to federal and state licensure requirements that are merely focused on the minimum thresholds to operate as a pharmacy and not the critical specialized services associated with the dispensing of specialty medications has the potential to cause irrevocable harm. I sincerely hope Governor Cuomo will consider the potential impact of this flawed legislation.  

Brittany McCullough

Brittany McCullough, Health Policy Associate.

Brittany McCullough, URAC's health policy associate, focuses on tracking and analyzing legislation and regulations of importance to URAC stakeholders. Brittany considers herself an early careerist but most of her policy and research work has been centered on the ACA, Medicaid, CHIP, and mental health. She holds a B.S. in Neuroscience and a Master of Health Administration.

Views, thoughts and opinions expressed in my articles belong solely to me, and not necessarily to my employer.

Comments

I TAKE ISSUE WITH YOUR TAKE ON PBMs

As I begin my journey as a patient as well as a retired pharmacist ( Hospital, Community and Government Pharmacy)
I have come to see PBMS as problematic for patients and Community Pharmacy

PRMs are not just involved in deciding what drugs are covered for patients - they get rebates from manufacturers
and decide which brand and generics are covered , what tier they are in, and what to do with patients whose
physicians do not want to or charge for the paperwork required to get prior authorizatins for uncovered drugs or drugs
used outside of the PBMs idea of what is medically aceptable.

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